Re‐evaluation of propane‐1,2‐diol (E 1520) as a food additive

Younes, Maged; Aggett, Peter; Aguilar, Fernando; Crebelli, Riccardo; Dusemund, Birgit; Filipič, Metka; Frutos, María José; Galtier, Pierre; Gott, David Michael; Gundert‐Remy, Ursula; Kuhnle, Gunter Georg; Leblanc, Jean‐Charles; Lillegaard, Inger Therese L.; Moldéus, Peter; Mortensen, Alicja; Oskarsson, Agneta; Stanković, Ivan; Waalkens‐Berendsen, Ine; Woutersen, Rudolf Antonius; Wright, Matthew; Boon, Polly; Chrysafidis, Dimitrios; Gürtler, Rainer; Mosesso, Pasquale; Parent‐Massin, D.; Tobback, Paul; Rincón, Ana María; Tard, Alexandra; Lambré, Claude

doi:10.2903/j.efsa.2018.5235

Cited by 13 publications

(21 citation statements)

References 59 publications

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“…The widespread use of e-cigs attracted significant attention from governmental bodies, scientists and the medical profession in relation to their possible effects on public health. One much debated issue in the scientific community and among International Organizations concerns the potential risks due to short-and long-term inhalation exposure to chemicals present in e-liquids as contaminants/impurities (i.e., aromatic hydrocarbons, heavy metals and aldehydes) and e-liquid main components (i.e., propylene glycol and glycerol), taking into account that, in the latter case, long-term effects by direct inhalation in the lung cannot be predicted even though their use as food additives is approved [8]. Finally, but not less important, concerns have arisen in relation to potential risks due to active and passive exposure (e.g., main stream and second-hand stream vaping) to ultrafine particles.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Second-Hand Exposure to Electronic Cigarette Vaping under a Real Scenario: Measurements of Ultrafine Particle Number Concentration and Size Distribution and Comparison with Traditional Tobacco Smoke

Palmisani

Gilio

Palmieri

et al. 2019

Toxics

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The present study aims to evaluate the impact of e-cig second-hand aerosol on indoor air quality in terms of ultrafine particles (UFPs) and potential inhalation exposure levels of passive bystanders. E-cig second-hand aerosol characteristics in terms of UFPs number concentration and size distribution exhaled by two volunteers vaping 15 different e-liquids inside a 49 m3 room and comparison with tobacco smoke are discussed. High temporal resolution measurements were performed under natural ventilation conditions to simulate a realistic exposure scenario. Results showed a systematic increase in UFPs number concentration (part cm−3) related to a 20-min vaping session (from 6.56 × 103 to 4.01 × 104 part cm−3), although this was one up to two order of magnitude lower than that produced by one tobacco cigarette consumption (from 1.12 × 105 to 1.46 × 105 part cm−3). E-cig second-hand aerosol size distribution exhibits a bimodal behavior with modes at 10.8 and 29.4 nm in contrast with the unimodal typical size distribution of tobacco smoke with peak mode at 100 nm. In the size range 6–26 nm, particles concentration in e-cig second-hand aerosol were from 2- (Dp = 25.5 nm) to 3800-fold (Dp = 9.31 nm) higher than in tobacco smoke highlighting that particles exhaled by users and potentially inhaled by bystanders are nano-sized with high penetration capacity into human airways.

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Section: Introductionmentioning

confidence: 99%

Evaluation of Second-Hand Exposure to Electronic Cigarette Vaping under a Real Scenario: Measurements of Ultrafine Particle Number Concentration and Size Distribution and Comparison with Traditional Tobacco Smoke

Palmisani

Gilio

Palmieri

et al. 2019

Toxics

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“…The SCF and JECFA used the study in rats to derive an ADI of 25 mg propane-1,2-diol/ kg bw per day using an uncertainty factor of 100. The Panel agreed with this ADI (EFSA ANS Panel, 2018).…”

Section: Alginic Acid and Derived Salts (E 400-404)mentioning

confidence: 74%

“…None of these studies demonstrated adverse effects.Propane-1,2-diol alginate was tested in several in vitro assays (point mutation in bacteria, chromosomal aberrations in mammalian cells) and in vivo (host-mediated assay, dominant lethal and bone marrow chromosome aberration in rat) that, despite some limitations, did not reveal any genotoxic effect. In addition, alginic acid and propane-1,2-diol, the two hydrolytic metabolites of propane-1,2-diol alginate, were considered by EFSA of no genotoxic concern (EFSA ANS Panel, 2017Panel, , 2018. The Panel therefore noted that the available data did not indicate a genotoxic concern for propane-1,2-diol alginate (E 405) when used as a food additive.Propane-1,2-diol alginate, alginic acid and propane-1,2-diol were not of concern with respect to carcinogenicity.…”

mentioning

confidence: 99%

Re‐evaluation of propane‐1,2‐diol alginate (E 405) as a food additive

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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The present opinion deals with the re-evaluation of propane-1,2-diol alginate (E 405) when used as a food additive. The Panel noted that absorption, distribution, metabolism and excretion (ADME) data on propane-1,2-diol alginate gave evidence for the hydrolysis of this additive into propane-1,2-diol and alginic acid. These two compounds have been recently re-evaluated for their safety of use as food additives (EFSA ANS Panel, 2017. Consequently, the Panel considered in this opinion the major toxicokinetic and toxicological data of these two hydrolytic derivatives. No adverse effects were reported in subacute and subchronic dietary studies with propane-1,2-diol alginate. The available data did not indicate a genotoxic concern for propane-1,2-diol alginate (E 405) when used as a food additive. Propane-1,2-diol alginate, alginic acid and propane-1,2-diol were not of concern with respect to carcinogenicity. The Panel considered that any adverse effect of propane-1,2-diol alginate would be due to propane-1,2-diol. Therefore, the acceptable daily intake (ADI) of the food additive E 405 is determined by the amount of free propane-1,2-diol and the propane-1,2-diol released from the food additive after hydrolysis. According to the EU specification, the concentration of free and bound propane-1,2-diol amounts to a maximum of 45% on a weight basis. On the worst-case assumption that 100% of propane-1,2-diol would be systemically available and considering the ADI for propane-1,2-diol of 25 mg/kg body weight (bw) per day, the Panel allocated an ADI of 55 mg/kg bw per day for propane-1,2-diol alginate. The Panel concluded that exposure estimates did not exceed the ADI in any of the population groups from the use of propane-1,2-diol alginate (E 405) as a food additive. Therefore, the Panel concluded that there is no safety concern at the authorised use levels.

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“…No treatment-related effects were observed in subchronic toxicity studies in which propane-1,2-diol was administered by gavage (1,000 mg/kg bw per day) to mice, rats, dogs and monkeys for 92-97 days (Thackaberry et al, 2010;EFSA ANS Panel, 2018a).…”

Section: Propane-12-diol (E 1520)mentioning

confidence: 99%

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Flavourings¹,

Younes²,

Aquilina³

et al. 2018

EFS2

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The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of propane-1,2-diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane-1,2-diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short-term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane-1,2-diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane-1,2-diol ester of fatty acids would be due to propane-1,2-diol, previously re-evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane-1,2-diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane-1,2-diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non-brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane-1,2-diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane-1,2-diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(12):5497 SummaryThe Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated propane-1,2-diol esters of fatty acids in 1974 and stated that there is evidence for hydrolysis of propane-1,2-diol esters of fatty acids resulting in the products propane-1,2-diol, for which an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day has previously established, and fatty acids. JECFA established an ADI of 25 mg/kg bw per day for propane-1,2-diol esters of fatty acids, this ADI was expressed as propane-1,2-dio...

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Re‐evaluation of propane‐1,2‐diol (E 1520) as a food additive

Cited by 13 publications

References 59 publications

Evaluation of Second-Hand Exposure to Electronic Cigarette Vaping under a Real Scenario: Measurements of Ultrafine Particle Number Concentration and Size Distribution and Comparison with Traditional Tobacco Smoke

Evaluation of Second-Hand Exposure to Electronic Cigarette Vaping under a Real Scenario: Measurements of Ultrafine Particle Number Concentration and Size Distribution and Comparison with Traditional Tobacco Smoke

Re‐evaluation of propane‐1,2‐diol alginate (E 405) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

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